efficacy and safety of neoadjuvant pembrolizumab in iii-iva resectable oral squamous cell carcinoma

Conditions: Oral Cavity Squamous Cell Carcinoma

Summary: the purpose of this prospective, single-center, single-arm, open-label ii phase observation clinical trial is to evaluate the efficacy and safety of pembrolizumab immunoadjuvant therapy in patients with stage iii-iva oral squamous cell carcinoma. the primary end point is the pathological tumor remission rate of the primary tumor and regional lymph nodes after neoadjuvant immunotherapy (ptr-2: the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections \> 50%). the secondary endpoints are 1-year disease-free survival (dfs), 1-year overall survival (os) and the incidence of adverse events, compared with historical data. in addition, we will check the relevant immune indicators, such as pd-l1 and cps scores.


Eligibility criteria:
inclusion criteria: * age 18-70 * male and female * patients histologically or cytologically difined as oral cavity squamous cell carcinoma * according to the american joint committee on cancer ( ajcc 8th edition ) , patients with resectable stage iii-iva ocscc * ecog performance status ≤ 1 * patients with normal bone marrow and organ function as defined below: blood routine examination: 1. absolute neutrophil count ≥ 1.5×109/l; 2. platelets ≥ 100.0×109/l; 3. hemoglobin ≥ 9.0 g/dl. liver function: 1. totle bilirubin ≤ 2.0×uln(upper limit of normal); 2. alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase * 2.5×uln; 3. albumin ≥ 2.8g/dl. renal function: (1)creatinine clearance rate \> 60.0ml/min. coagulation function: (1)international normalized ratio ≤ 1.5；activated partial thromboplastin time ≤ 1.5×uln * prior to and during study, and lasting 120 days for the final utilization of pembrolizumab, patients approve of contraception * patients voluntarily agree to participate in the study and sign the informed consent form exclusion criteria: * prior treatment for ocscc (sugery, immunotherapy, radiotherapy, chemotherapy) * patients with metastatic ocscc with an unknown primary tumor site * patients with infectious disease: aids, hepatitis, active tuberculosis * received a live vaccine within 30 days prior to the first dose of pembrolizumab. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, bacillus calmette-guérin ( bcg ), typhoid vaccine, or attenuated flu vaccine * 5.has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab * currently receiving any other investigational agents * has a history of allergic reactions attributed to compounds of similar chemical of biologic composition to pembrolizumab or other agents used in the study * patients with ongoing or active infectoin requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements * has a or more active autoimmune disease * has a history( non-infectious ) pneumonitis that required steroids or current pneumonitis